METHYLPHENIDATE TREATMENT OF ADHD IN CHILDREN WITH TS
METHYLPHENIDATE TREATMENT OF ADHD IN CHILDREN WITH TS
批准号:
2415929
负责人:
KENNETH D GADOW
金额:
$19.49万
依托单位国家:
美国
项目类别:
财政年份:
1991
资助国家:
美国
项目状态:
已结题
起止时间:
1991-02-01 至 1999-04-30
中文摘要
在我们诊所进行的研究和在其他大学进行的调查
研究中心清楚地表明,注意力缺陷多动障碍
注意力缺陷多动障碍(ADHD)是抽动秽语综合征(TS)的常见行为伴随物,
儿童患者。 对于许多人来说,ADHD症状是一个更大的
比他们的抽搐更阻碍社交和学术成功,特别是
在小学的时候。 不幸的是最安全的
有效的,广泛使用的药物治疗多动症,即
哌甲酯,被广泛认为是加剧TS症状,因此
这类患者禁用。 (1)药理学
哌甲酯的替代品通常与增加的风险有关,
不良反应(例如,精神抑制剂)或对于延长的
使用(例如,丙咪嗪)和(B)很少有研究
哌甲酯在TS患者中的应用,我们认为迫切需要
检查哌甲酯对ADHD和TS症状的安全性和有效性
并制定临床应用的药物评价程序。
此外,这样的研究可以提供洞察TS的神经生理学。
在这项拟议的研究中,20名6至12岁的男孩被诊断为
同时患有ADHD和TS的患者将进入为期八周的安慰剂组,
哌醋甲酯的对照、双盲交叉研究。 药物
条件将由安慰剂和.1、.3和.5 mg/kg的
哌醋甲酯每天给药两次,每次持续两周。 药物
将被分发在日期信封,患者将被随机
分配给平衡剂量序列。 两者的药物反应性
将使用直接观察程序评估ADHD和TS症状
在学校和诊所的游戏室,实验室的性能测试,
临床医生、教师和家长评定量表。 安慰剂对照,
将进行双盲事件相关电位(ERP)研究
药物评价后立即检查药物相关
大脑功能的变化。 我们实验室正在进行的ERP研究将
允许研究样本与正常和ADHD儿童之间的比较。
拟议研究的最后阶段是为期六个月的随访,
时间ADHD和TS症状将定期评估,以确定变化
随着时间
英文摘要
Research conducted in our clinic and investigations in other university
centers clearly indicate that Attention-Deficit Hyperactivity Disorder
(ADHD) is a common behavioral concomitant of Tourette syndrome (TS) in
child patients. For many individuals, ADHD symptoms are a greater
impediment to social and academic success than their tics, particularly
during the elementary school years. Unfortunately, the most safe,
effective, and widely used pharmacological treatment for ADHD, namely
methylphenidate, is widely thought to exacerbate TS symptoms and therefore
to be contraindicated in such patients. Because (a) the pharmacological
alternatives to methylphenidate are often associated with increased risk of
adverse reactions (e.g., neuroleptics) or are less efficacious for extended
use (e.g., imipramine) and (b) there is very little research on
methylphenidate in TS patients, we believe that a compelling need exists to
examine the safety and efficacy of methylphenidate for ADHD and TS symptoms
and to develop drug evaluation procedures for clinical application.
Further, such research may provide insight into the neurophysiology of TS.
For the proposed study, 20 boys between 6 and 12 years of age and diagnosed
as having both ADHD and TS will be entered into an eight-week placebo
controlled, double-blind crossover study of methylphenidate. Drug
conditions will consist of placebo and .1, .3, and .5 mg/kg of
methylphenidate administered twice daily, each for two weeks. Medication
will be dispenced in dated envelopes, and patients will be randomly
assigned to counterbalanced dosage sequences. Drug responsivity of both
ADHD and TS symptoms will be assessed using direct observation procedures
in the school and in the clinic playroom, laboratory performance tests, and
clinician, teacher, and parent rating scales. A placebo controlled,
double-blind event-related potential (ERP) study will be conducted
immediately following the medication evaluation to examine drug related
changes in brain function. Ongoing ERP studies in our laboratory will
permit comparisons between the study sample and normal and ADHD children.
The final phase of the proposed study is a six-month followup during which
time ADHD and TS symptoms will be routinely assessed to determine changes
over time.
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海外基金